Quality in Development

Pharmaceutical development is a critical component of bringing safe, effective, and high-quality medicines to market. Early decisions made during the research phase have a significant impact on the product and must be included in regulatory submissions.

Quality Management in pharmaceutical development refers to the systematic process of ensuring that all stages of drug development — from research to commercialization — meet regulatory standards, maintain product safety and efficacy and is appropriately documented. This also ensures that intellectual property rights (IPR) are safeguarded.

Services include:

  • CMC advisory
  • Implementing a phase appropriate QMS
  • Risk management
  • Providing scientific support for Manufacturing, Science & Technology (MSAT) service
  • Tech transfer of manufacturing and development activities (e.g process design, validation, and optimization)
  • Contamination control strategies
  • Analytical development (ICH Q14) and validation (ICH Q2)

Contact One Of Our Experts

Our people are the true driving force behind our success. We’ve assembled an incredible team of experts who come from diverse backgrounds, but they all share a common thread: a genuine passion for their industry and an unwavering commitment to exceeding our clients’ expectations.

Britt Dam Raaby

Britt Dam Raaby

Vice President